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NCT01777451 Clinical Trial

Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis

Magnetic Resonance Imaging Clinical Trial

— NEFIMAR  

Official title:
Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01777451
Other study ID # NEFIMAR
Secondary ID S52684
Status Recruiting
Phase N/A
First received January 23, 2013
Last updated January 23, 2013
Start date December 2010
Est. completion date January 2014

Study information
Verified date January 2013
Source Universitaire Ziekenhuizen Leuven
Contact Steven Pans, MD
Phone 3216340505s
Email steven.pans@uzleuven.be
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial Summary

Whole body MRI will be performed in patients with neurofibromatosis Type 1

PURPOSE 1:

To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or malignant peripheral nerve sheath tumors. All patients will be scanned two years after the baseline whole body MRI to investigate to investigate the changes of total tumor load.

PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas

PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath tumors and neurofibroma.

PURPOSE 4 : correlation between histopathology of the surgically resected neurofibroma/malignant nerve sheath tumors and MRI findings

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date January 2014
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 50 Years
Eligibility Inclusion Criteria:

- Patients with neurofibromatosis type 1, between 6 and 50 years old

Exclusion Criteria:

- Patients who are not allowed to be scanned on MRI (contra-indications: pacemaker ed.)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Additional imaging or surgery
No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)

Locations
Country Name City State
Belgium University Hospitals Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Cai W, Kassarjian A, Bredella MA, Harris GJ, Yoshida H, Mautner VF, Wenzel R, Plotkin SR. Tumor burden in patients with neurofibromatosis types 1 and 2 and schwannomatosis: determination on whole-body MR images. Radiology. 2009 Mar;250(3):665-73. doi: 10.1148/radiol.2503080700. — View Citation

Tucker T, Friedman JM, Friedrich RE, Wenzel R, Fünsterer C, Mautner VF. Longitudinal study of neurofibromatosis 1 associated plexiform neurofibromas. J Med Genet. 2009 Feb;46(2):81-5. doi: 10.1136/jmg.2008.061051. Epub 2008 Oct 17. — View Citation

Van Meerbeeck SF, Verstraete KL, Janssens S, Mortier G. Whole body MR imaging in neurofibromatosis type 1. Eur J Radiol. 2009 Feb;69(2):236-42. doi: 10.1016/j.ejrad.2008.10.024. Epub 2008 Dec 16. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Estimation of total tumor load and diagnosis of high-risk neurofibromas Estimation of the total tumor load of neurofibromas with whole body MRI (head to knee). Diagnosis of high risk neurofibroma in the chest, abdomen, pelvis, and extremities with T2-weighted sequence and diffusion weighted sequence. 1 month No
Secondary To diagnose high-risk neurofibroma Some patients with neurofibromatosis have lesions, pre-malignant or malignant neurofibromas. Additional imaging (PET-CT), a biopsy or surgical treatment is necessary in combination with histopathology of the lesion. 2 months No
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